EXCLUSIVE: Envoy Medical Builds Momentum With Improved Cochlear Implant Trial Results

Envoy Medical Inc. (NASDAQ: COCH ) on Tuesday reported 12-month results from the first 10 participants in Stage 1 of its pivotal clinical trial evaluating the investigational fully implanted Acclaim cochlear implant, with hearing performance continuing to improve over previously reported six-month data.

The company said participants achieved a mean Consonant-Nucleus-Consonant (CNC) word recognition score of 53.2% at the 12-month mark, compared with a pre-implantation baseline of 15.2%.

The 38.0 percentage point improvement exceeded the 24.0 percentage point gain reported after six months, when the cohort posted a mean score of 39.2%.

Read Also: EXCLUSIVE: Envoy Medical Hits Trial Milestone For Cochlear Implant Designed To Work With Natural Ear The 12-month data will serve as the primary efficacy endpoint for the Acclaim pivotal clinical study.

Majority Of Patients Showed Positive Response Nine of the 10 Stage 1 participants demonstrated hearing improvements consistent with the overall trend, while one participant was identified as a potential non-responder.

Envoy Medical said it is reviewing the underlying cause of that outcome.

Excluding the potential non-responder, the remaining nine participants recorded a mean CNC word recognition score of 59.1% at 12 months, representing a 42.2 percentage point improvement from baseline.

On the safety front, the company reported no serious adverse events, as defined by the study protocol, among the first 10 participants through their 12-month follow-up visits.

Envoy Medical Says Stage 2 Enrollment Complete The completion of the 12-month assessments marks the end of primary endpoint follow-up for Stage 1 of Envoy Medical’s two-stage pivotal trial.

Following FDA authorization to expand the study, the company moved into Stage 2, which is now fully enrolled.

All participants have completed their one-month visits, while many have also reached their three- and six- month follow-up milestones.

The company is collecting additional study measures and will include them in its planned FDA Premarket Approval submission.

Envoy Medical expects all Stage 2 participants to complete their 12-month follow-up by the early second quarter of 2027, with a Premarket Approval submission planned several months later.

COCH Price Action: Envoy Medical shares were down 3.24% at $0.67 during premarket trading on Tuesday, according to Pro data.

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